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临床试验/NCT04453124
NCT04453124已完成2 期

An Accessible Low-cost Plant Treatment for Cutaneous Ulcers

Oriol Mitja3 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年11月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
150
试验地点
3
主要终点
Number of participants with Clinical Healing in each arm

研究概览

简要总结

In a search for accessible treatment options, plant medicines used by different communities in Papua New Guinea have been tested to identify the sap of the tree, Ficus septica, as a promising antibacterial agent in vitro.

This is an open label clinical trial using an interventional approach, to compare the effect of the antiseptic plant sap and standard topical antiseptic, on the rate of wound development prevention and bacterial growth. If shown to be effective, this readily available plant medicine can provide a zero-cost treatment option in remote areas of PNG.

详细描述

The cutaneous ulcer is a painful and debilitating bacterial infection that is common in rural areas of Papua New Guinea (PNG). Systematic treatment with topical antiseptics such as chlorhexidine cream in theory represents a viable treatment option, but in reality, effective treatment of cutaneous ulcers in Papua New Guinea is greatly hindered by the remote and highly inaccessible areas that affected communities often live in. In a search for more accessible treatment options, plant medicines used by different communities in Papua New Guinea have been tested to identified the sap of the tree, Ficus septica, as a promising antibacterial agent in vitro. The sap displays comparable activity to chlorhexidine in disc diffusion assays with gram-positive bacterial wound pathogens. It also appears to dampen the pro-inflammatory responses of neutrophils by down regulating interleukin-6 expression. The sap forms a flexible plastic-like wound covering which may help deter flies from feeding on the wounds, and unlike chlorhexidine cream, the Ficus tree is easy to find where affected communities live. For this reason, this study aims to perform an open label clinical trial using an interventional approach, to compare the effect of this antiseptic plant sap and of a standard topical antiseptic, on the rate of wound development prevention and bacterial growth. If shown to be effective, this readily available plant medicine can provide a zero-cost treatment option in remote areas of PNG.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Assessor of healing outcomes through pictures will not know the arm of origen of the pictures .

入排标准

年龄范围
5 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children aged 5 to 15 with parental consent and with one or more skin breaks of any nature (i.e. Skin cuts, scratch, scrapes or abrasion and mosquito bites) that are less than 1cm in major diameter. Written informed consent by parent or guardian will be required before enrolment.

排除标准

  • All participants who have received medical treatment for skin ulcers up to 2 months prior to recruitment (azithromycin, amoxicillin, benzathine penicillin, etc.).
  • Patients who require antibiotic treatment for another condition not-related to the study.
  • Known history of hypersensitivity, allergic or adverse reaction to the study product.
  • Patients presenting cutaneous ulcer more than 1cm

结局指标

主要结局

Number of participants with Clinical Healing in each arm

时间窗: 21 days

surface reduction by more than 50%

次要结局

  • Changes in wound microbiology(21 days)

研究者

发起方
Oriol Mitja
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Oriol Mitja

Dr. Oriol Mitja

Lihir Medical Centre

研究点 (3)

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